Novel Treatment Gains Accelerated Approval for Relapsed/Refractory Neuroblastoma
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.
For patients with glioblastoma, short delays in the initiation of chemoradiotherapy after surgery were not linked to worse survival — yet initiation too soon was.
Disparities for disease severity not seen at diagnosis, meaning postdiagnosis factors may affect outcome.
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
Primary central nervous system lymphoma (PCNSL) is a rare (incidence rate of 0.6 cases per 100,000 person years) non-Hodgkin lymphoma (NHL) found in the brain, spinal cord, and leptomeninges.
The addition of bevacizumab to temozolomide-based chemotherapy was also associated with higher rates of grade 3 or higher thrombocytopenia and anemia.
According to the authors, treatment of patients with Bing-Neel syndrome should involve the use of CNS-penetrating approaches.
A phase 0 study of ribociclib in patients with recurrent glioblastoma seeks to inform the feasibility of the use of CDK 4/6 inhibitors for deadly brain tumors.
For specific subsets of patients with intermediate-risk neuroblastoma, an algorithm successfully reduced treatment while maintaining survival outcomes.